Actively Recruiting
A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
52
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a study medication called MK-1403 in people with type 2 diabetes mellitus (T2DM). This research also looks at how MK-1403 behaves in the body over time (pharmacokinetics) and its effect on levels of high-sensitivity C-reactive protein (hsCRP), a marker in the blood related to inflammation. The study is a Phase 1 clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will be randomly assigned to one of four groups. Some will receive MK-1403 combined with an additive coformulation at one of two dose levels, taken orally once daily. Others will receive a matching placebo with the same additive coformulation at the same dose levels, also taken once daily. This study uses a triple-blind design to ensure unbiased results, and treatment duration is approximately 14 to 28 days. During the study, participants will be closely monitored for any adverse events and their ability to tolerate the study medication. Blood samples will be taken to measure MK-1403 concentration 24 hours after dosing on Day 14 and to assess changes in hsCRP levels. The main outcomes include counting participants who experience side effects or stop treatment due to these effects. The entire participant involvement is planned to last up to about 28 days, focusing on safety and biological responses.
CONDITIONS
Brief Title
A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)
- Has body mass index (BMI) between 18 and 40 kg/m^2, inclusive
- Is between 18 and 75 years old
You will not qualify if you...
- Has Type 1 diabetes mellitus or secondary types of diabetes
- Has a history of congestive heart failure (New York Heart Association [NYHA] Class 3 or 4)
- Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke
- Has history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)
- Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 28 days
Participants receive MK-1403 or placebo with additive coformulation orally once daily as part of the study treatment.
Multiple visits during treatment for dosing and assessments
Trial Site Locations
Total: 4 locations
1
ProSciento Inc. ( Site 0001)
Chula Vista, California, United States, 91911
Actively Recruiting
2
Advanced Pharma CR, LLC ( Site 0003)
Miami, Florida, United States, 33147
Actively Recruiting
3
QPS-MRA, LLC ( Site 0004)
South Miami, Florida, United States, 33143
Actively Recruiting
4
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)
Springfield, Missouri, United States, 65802
Active, Not Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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